User Acceptability of a Device-Based Opioid Overdose Intervention

NCT04530591 | Completed Results

• 1 other identifier: 834304
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.

Conditions

Opioid Overdose; Opioid-use Disorder; Substance Use Disorders

Keywords

Naloxone Delivery; Survey

Outcome Measures

Primary Outcomes (1)

• Community Need for a Device-based Opioid Overdose Intervention

  We aim to characterize the degree of need for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview.

  Day 1

Secondary Outcomes (1)

• Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention

  Day 1

Study Arms (1)

Patient Participants

This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device.

Other: Survey; Other: Interview

Interventions

Survey OTHER

Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.

Patient Participants

Interview OTHER

Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device.

Patient Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is non-pregnant individuals over the age of 21 with opioid use disorder.

You may qualify if:

• Have used opioids for more than 3 months or will be having surgery where opioids will be administered
• Able to provide informed consent
• Moderate to severe chronic pain treated with opioids or recreational use

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Prevention Point Philadelphia

Philadelphia, Pennsylvania, 19134, United States

Location

Related Publications (1)

• Kanter K, Gallagher R, Eweje F, Lee A, Gordon D, Landy S, Gasior J, Soto-Calderon H, Cronholm PF, Cocchiaro B, Weimer J, Roth A, Lankenau S, Brenner J. Willingness to use a wearable device capable of detecting and reversing overdose among people who use opioids in Philadelphia. Harm Reduct J. 2021 Jul 23;18(1):75. doi: 10.1186/s12954-021-00522-3.

  PMID: 34301246 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Opioid-Related Disorders; Substance-Related Disorders

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Chemically-Induced Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Jacob Brenner, Assistant Professor of Medicine
• Organization: Hospital of the University of Pennsylvania

Jacob.Brenner@pennmedicine.upenn.edu

215-662-2222

Study Officials

• Jacob Brenner, MD/PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: August 25, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: July 7, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)